HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA

K120920 · Hsiner Company · BZD · Jul 16, 2012 · Anesthesiology

Device Facts

• Record ID: K120920
• Device Name: HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
• Applicant: Hsiner Company
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician. The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.

Device Story

Hsiner Pediatric CPAP Silicone Nasal Mask and Hsiner Nasal Pillow Mask are CPAP/VPAP interface devices; used to deliver positive airway pressure therapy to patients. Devices function as patient-worn masks/pillows; interface with CPAP/VPAP machines to provide respiratory support. Used in home, hospital, or institutional environments under physician prescription. No electronic components; purely mechanical interface. Benefit: facilitates delivery of prescribed airway pressure therapy to patients > 30 kg.

Clinical Evidence

No clinical data performed. Bench testing conducted per ISO 17510-2 (2007) for resistance to flow and CO2 rebreathing. Results confirmed devices meet requirements with no significant differences compared to predicates.

Technological Characteristics

Silicone nasal masks and nasal pillow masks. Mechanical interface for CPAP/VPAP therapy. Tested for flow resistance and CO2 rebreathing per ISO 17510-2 (2007). No electronic components, software, or energy sources.

Indications for Use

Indicated for patients > 30 kg prescribed CPAP/VPAP therapy in home, hospital, or institutional settings under physician direction.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Hsiner CPAP/VPAP Nasal Masks (K063268)
• ResMed's Mirage Kidsta Mask (K060105)
• ResMed's PixiTM Pediatric Mask (K102224)
• Respironics' GoLife Nasal Mask (K102502)

Submission Summary (Full Text)

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#### K120920 510(k) Summary 13.

In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.

#### Date: 07/11/2012 13.1.

#### 13.2. Submitter Information

Hsiner Company, LTD No. 13, Tyan Shin St., Taya Hsiang Taichung Hsien, Taiwan, ROC

Phone: [phone]

Registration No.: 3003862188 Owner/Operator No .: 9053474

#### Name of Device 13.3.

Proprietary Names:

- 1. Hsiner Pediatric CPAP Silicone Nasal Masks
- 2. Hsiner Nasal Pillow Mask

Common Name: CPAP Mask Classification Name: Noncontinuous ventilator (IPPB)

Product Code: BZD Regulation Number: 868.5905 Device Class 2

#### Substantially equivalent to: 13.4.

This submission compares the Hsiner extension devices to Hsiner's CPAP/VPAP Masks (K K063268) in addition to the following predicate devices;

- Hsiner Pediatric CPAP Silicone Nasal Mask to the Hsiner CPAP/VPAP Nasal Masks 1. (K063268)and ResMed's Mirage Kidsta Mask (K060105) and ResMeds PixiTM Pediatric Mask (K 102224),
- Hsiner Nasal Pillow Mask to Repironics' GoLife Nasal Mask (K102502). 2.

#### Comparison to Predicate Devices 13.5.

There are no technological differences between these devices.

### 13.5.1. Design, Materials and Intended Use

The Hsiner CPAP Silicone Nasal Mask and Hsiner Nasal Pillow Mask devices, accessories, attachments, principles of operation and materials are all essentially equivalent to predicate devices already cleared by FDA. The Hsiner, ResMed and Respironics devices operate on the same principles and have the same intended use.

#### 13.6. Description of the device

Hsiner's Pediatric CPAP Silicone Nasal Mask and Hsiner's Nasal Pillow Mask are both product line extensions to their existing line of CPAP interface devices for the application of CPAP/VPAP therapy.

Modified 07/11/2012

1:

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#### Intended Use of the Device 13.7.

- 1. Hsiner Pediatric CPAP Silicone Nasal Masks: - The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
- 2. Hsiner Nasal Pillow Mask: The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.

#### Clinical-Performance Evaluations 13.8.

No clinical test was performed for this device

#### Performance Evaluation 13.9.

The performance test protocols for Hsiner's line extensions follow appropriate sections of ISO 17510-2 (2007): "Sleep apnea breathing therapy-Part 2: Masks and application accessories."

- 1. Hsiner's Pediatric CPAP Silicone Nasal Mask was found to be well below the resistance to flow and CO2 rebreathing requirement identified in ISO 17510-2.
- Hsiner's Nasal Pillow Mask was found to be well below the resistance to flow and CO2 2. rebreathing requirement identified in ISO 17510-2.

### 13.10. Conclusion

- · Performance evaluation concludes that all the devices meet the requirements associated with ISO 17510-2 "Sleep apnea breathing therapy-Part 2: Masks and application accessories" and that there are no significant differences in resistance to flow and CO2. rebreathing.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the eagle.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

JUL 16 2012

Hsiner Company C/O Mr. Tom Shanks MD Ventures 29201 Via Norte Temecula, California 92591

Re: K120920

Trade/Device Name: Hsiner CPAP Nasal Pillow Mask, Hsiner Pediatric CPAP Silicone Nasal Masks Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 29, 2012 Received: July 2, 2012

Dear Mr. Shanks:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Shanks

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Anthony D. Watson. B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number :

Hsiner CPAP Nasal Pillow Mask Device Name:

### Indications for Use:

The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 120920 Page 1 of 1

Modified 07/11/2012

Page 17

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## Indications for Use

### 510(k) Number:

Hsiner Pediatric CPAP Silicone Nasal Masks Device Name:

### Indications for Use:

The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) ·

BELOW THIS LINE-CONTINUE ON (PLEASE DO NOT WRITE ANOTHER PAGE IF NEEDED)

Office of Device Evaluation (ODE) Page 1 of 1 Concurrence of CDRF

> (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Modified 07/11/2012

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